A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734*) in Participants with Moderate COVID-19 Compared to Standard of Care Treatment - Remdesivir in Participants with Moderate COVID-19

Gilead Sciences0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•Subjects must meet all of the following inclusion criteria to be eligible for
•participation in this study:
•1) Willing and able to provide written informed consent (participants >= 18
•years of age) or assent (participants >= 12 and < 18 years of age,
•where locally and nationally approved) prior to performing study procedures.
•For participants >= 12 and < 18 years of age, a parent or
•legal guardian willing and able to provide written informed consent prior to
•performing study procedures
•2) Aged >= 18 years (at all sites), or aged >= 12 and < 18 years of age weighing
•>= 40 kg (where permitted according to local law and approved nationally and by
•the relevant IRB/IEC)
•3) SARS-CoV-2 infection confirmed by PCR <= 4 days before randomization
•4) Currently hospitalized and requiring medical care for COVID-19
•5) SpO2 > 94% on room air at screening
•6) Radiographic evidence of pulmonary infiltrates
•7) Men and women of childbearing potential who engage in heterosexual
•intercourse must agree to use protocol specified method(s) of contraception as
•described in Protocol Appendix 3.

•Subjects who meet anyof the following exclusion criteria are not to be enrolled
•in this study:
•1) Participation in any other clinical trial of an experimental agent treatment
•for COVID-19
•2) Concurrent treatment or planned concurrent treatment with other agents with
•actual or possible direct acting antiviral activity against SARS-CoV-2
•3) Requiring mechanical ventilation at screening
•4) ALT or AST > 5 x ULN
•Note: if per local practice only ALT is routinely is routinely measured,
•exclusion criteria will be evaluated on ALT alone
•5) Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for
•participants >= 18 years of age {Cockcroft 1976} and Schwartz Formula for
•participants < 18 years of age
•6) Positive pregnancy test (Protocol Appendix 3)
•7) Breastfeeding woman
•8) Known hypersensitivity to the study drug, the metabolites, or formulation

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